Autologous fat-derived stem cell treatment for early Alzheimer's disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 1b/2a trial will treat 12 adults with late pre-symptomatic or prodromal Alzheimer's disease with four IV infusions of autologous, adipose-derived mesenchymal stem cells over a 13-week period. Stem cells are harvested from a small fat biopsy, processed, and returned to participants by vein to target neuroinflammation. Participants must have evidence of brain amyloidosis and an elevated peripheral inflammatory profile and will undergo MRI, cognitive testing, blood biomarker assays, and regular clinic visits for about one year. The primary aims are to characterize safety and tolerability and to see if the treatment lowers neuroinflammation, changes brain activity, or slows progression toward Alzheimer's disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Has signed an informed consent form before any assessment is performed as part of the study.
2. Be male or female between 60 and 80 years old.
3. Subject has been or is in process of being clinically diagnosed with late pre-symptomatic or mild cognitive impairment (MCI) due to AD (prodromal AD).
4. Mini-Mental State Examination (MMSE) score of ≥ 22
5. Has an MRI to evaluate AD pathology (may use previous if within 6mo.)
6. Has APOE status to evaluate AD pathology (may use previous result)
7. Proficiency in English is required because cognitive tests are administered in English only.
8. Has evidence of brain amyloidosis via PET Scan or Aβ42/40 ratios in CSF.
9. Has evidence of peripheral inflammatory profile based on CRP (≥ 8 mg/L), IL-6 (≥ 3.1 pg/mL), TNF-α (10 pg/mL), or erythrocyte sedimentation rate (ESR) (≥20 mm/h) in blood assays.
10. Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.

Exclusion Criteria:

1. Current medical or neurological condition that might impact cognition or performance on cognitive assessments. (e.g., traumatic brain injury (TBI), Parkinson's disease (PD), multiple sclerosis, etc.)
2. Inability or unwillingness of patient to undergo neuropsychological testing.
3. Advanced, severe, progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the subject at special risk. (e.g., significant cardiac disease, severe renal impairment, severe hepatic impairment, autoimmune disease, etc.)
4. History of malignancy of any organ system within the past 60 months, that in the opinion of the investigator would impede evaluation or interpretation of subject safety or study results.
5. Females of childbearing potential must not be pregnant.
6. Inability or unwillingness to undergo PET Scans.
7. Inability or unwillingness to undergo MRI Scans.
8. Positive blood test for either HIV, Hepatitis B, Hepatitis C or Syphilis
9. Positive for TSPO SNP rs6971
10. Inability or unwillingness to undergo Lumbar Punctures.
11. Inability or unwillingness to undergo infusions.
12. Any condition, which in the opinion of the investigator, would put the subject at undue risk or would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

Where it's running

• The University of Texas Health Science Center at Houston (UTHealth)
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Paul E Schulz, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Harshali Patel
• Email: Harshali.Patel@uth.tmc.edu
• Phone: 713-486-0531

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• New flutemetamol F18 formulation to see if it works as well as current for brain amyloid imaging

  Researchers are testing a new flutemetamol F18 formulation (GE-287) to see if it identifies brain amyloid as accurately as the current formulation in people 50 and older who are undergoing amyloid PET scans for cognitive decline.

  Recruiting at 5 sites Phase 2 GE Healthcare · Aventura, Florida and 5 other locations · NCT07873463

• Longevity Metrics AI/ML Development Study

  Researchers are testing AI models that score health screening tests and predict outcomes like life expectancy for adults, using ongoing follow-up data.

  Recruiting Longevity Metrics, Inc. · Boulder, Colorado · NCT07808619

• Immersive nature-based wellbeing program for older adults with cognitive impairment

  A nature-inspired immersive virtual reality program is being tested to see if it can improve well-being and daily function for older adults with mild to moderate cognitive impairment.

  Recruiting Consorci Sanitari de Terrassa · Terrassa, Barcelona · NCT07802392

• Hesperidin for better thinking in overweight older adults

  In adults aged 55–75 who are overweight, taking hesperidin or a placebo for 10 weeks will show whether the citrus flavonoid can improve thinking skills like memory, attention, and problem-solving.

  Recruiting University of Glasgow · Shanghai, Shanghai Municipality · NCT07750223

• Structured Receptive Music to Help with Care During Bathing for People with Dementia

  A structured daily music program used during hygiene care is being tested to see if it reduces refusals of care by residents with dementia in French nursing homes.

  Recruiting at 6 sites Lna Sante · Amiens and 11 other locations · NCT07730957

• Risk of delirium and cognitive problems after TUR-P in older adults

  This study tests whether certain perioperative factors can predict delirium and postoperative cognitive dysfunction in people aged 65 and older undergoing transurethral resection.

  Recruiting Muğla Sıtkı Koçman University · Muğla · NCT07719712

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.